1. Field of Invention
This invention relates to the field of medical devices, specifically to a positive pressure producing rectal collection pad aimed at coping with and countering the effects of bowel incontinence.
2. Background of the Invention
Fecal incontinence is an uncomfortable, inconvenient and embarrassing condition, which is experienced by upwards of twenty percent of the world's population. It can result from many afflictions including: irritable bowel syndrome, colitis, post-colorectal cancer surgery and or pelvic radiation treatments, transient illnesses and a broad array of prescription medications. Prior attempts to alleviate the symptoms of this problem have been to some degree inadequate. Bowel compromised individuals experience periodic episodes of intestinal peristaltic waves of urgency from food intake and or nervous stimuli, resulting in accidental soiling and or immediate need to go to toilet. Irritable bowel produces a concomitant mixture of intestinal gas and downward movement of fecal material through the intestinal tract.
The anal sphincter can also overestimate this fecal accumulation such that it wants to release rather than wait for adequate residue to produce a normal bowel movement. Furthermore, the sphincter has a diminished capacity to distinguish between gaseous and solid buildup, contributing further to incontinence. A normal functioning sphincter can permit gaseous discharge while blocking solid material discharge. Current treatments for bowel incontinence include bulky diapers and undergarments, dietary control, medications, psychological counseling, and other proposed perineal specific dressings. Specifically concerning the latter, functional rectal incontinence pads have been proposed to address acute symptoms. People suffering from fecal incontinence generally experience a diminished quality of life as a result of this affliction and prior art's inadequate solution to addressing this problem.
Prior arts'rectal pads have attempted to solve the problem of fecal incontinence by serving as collection devices of varied shapes and sizes which simply rest in the gluteal cleft, and serve as a barrier and a receptacle for involuntary discharge of anal contents. Though attempting to address the problem of discharge collection, these rectal pads still have significant shortcomings inherent to their design and construction. The void existing between the pads'superior surface and anal opening can allow for an undesirable residue to persist in spite of the pad's presence. Therefore, a solution is needed to supersede the prior arts'inadequate designs and sole ability to passively collect the effects of an accidental release of fecal material. The remedy to prior arts' shortcomings comprises a pad of vastly improved ergonomic design. One which has a pressure inducing non-invasive nodule feature that actively helps a sufferer of fecal incontinence to stave off bowel urges with greater success and comfort, and ultimately gain greater ability to control bowel urges through the unique dynamic features of this device.
The rectal pad in U.S. Pat. No. 4,084,919 to Sohn et al. lacks significant ergonomics insofar that the device is a straight, rather substantial and inflexible wedge, that does not promote truly intimate contact with the anal region. Though it serves as a wide barrier to collect any accidental discharge, the issue of comfort is questionable with the wearer sitting down or engaging in vigorous activity. Furthermore, the adhesive fasteners comprises two opposed rather elongated strips which complicate implementation of the device, and also demands greater time applying and changing during frequent bouts of accidental discharge. This is particularly unfavorable in public or workplace environments where time and location may factor heavily. Also questionable, due to the adhesive means of fastening, is the ability for the device to remain functional during prolonged exposure to moisture, sweat, water, etc. Failure of the fastener could result in dislodgement of the pad and an unhygienic result. Ultimately, the opposing attachment straps beginning high above the posterior portion of the anal fold, must then complete attachment within the anterior genital region, making it exceedingly difficult for attachment. The question of comfort for males and females alike with this arrangement is entirely dubious.
The rectal absorption pad in U.S. Pat. No. 6,461,341 to J. H. Bennett, a towelette structure, falls short insofar as having a lack of substance, ergonomics and structure. The claimed benefit to such a structure is that minimal sensation within the region is preferable. Based upon these assertions, it must be called into question whether the thinness of a tissue like device is of adequate substance to absorb a potentially heavy release. Also, the touted dual function of an anal and vaginal urine collection device greatly limits the scope of this pad to an essentially female sector. Furthermore, the device assumes that a dual-purpose function is necessary to begin with. Lastly, the flaccid nature of a towel structure, calls into question the hygienic removal of this pad. Although having an extraction tab, it is entirely possible for the folded towel to unfurl during removal greatly increasing the possibility for undesirable fecal/body contact.
The anal patch for fecal incontinence in U.S. Pat. No. 5,695,484 to B. J. Cox proposes a flat circular patch folded into a concave saddle like orientation. Although the curvature ergonomically accommodates the anal cleft, it fails to engage intimately with the anal region, the feature most necessary to adequately ensure maximal protection. Though a proposed embodiment features a more intimate nipple structure, it is rather anemic and unsubstantial calling into question its functional value. Furthermore, this particular embodiment purports to have an invasive ability, which in terms of comfort must be greatly questioned, especially by those who would prefer more intimate contact but wish to avoid potential invasion to the anal opening. Lastly, insertion and retention of the anal patch, is accomplished by an adhesive vehicle applied to the patch. Those with frequent or chronic incontinence symptoms could most certainly experience a considerable degree of dermal irritation associated with chronic exposure and removal of an adhesive based device in this most sensitive region of the body.